BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4102241 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17380
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    February 26, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DOSAGE NEEDED TO BE INCREASED, BUT BEFORE THAT COULD BE DONE, AN MRI WAS NEEDED TO MAKE SURE EVERYTHING WAS FINE. TWO DAYS LATER, IT WAS REPORTED THERE WAS AN INFLAMMATORY MASS AND THE GRANULOMA WAS FOUND DURING THE MRI TO EVALUATE THE CATHETER. LATER IT WAS REPORTED THAT THE PHYSICIAN WOULD WAIT TO RULE OUT GRANULOMA BEFORE INCREASING THE DOSE SO IT WAS UNCLEAR IF GRANULOMA HAD BEEN OFFICIALLY DIAGNOSED. THE PATIENT HAD INCREASED PAIN FOR THE LAST 6 MONTHS. THE PATIENT HAD NO NEUROLOGICAL DEFICIT AS OF THE TIME OF THE REPORT. THE SYSTEM WAS BEING USED TO DELIVER MORPHINE. FOLLOW-UP HAS BEEN CONDUCTED TO DETERMINE INFORMATION REGARDING THE SPECIFIC DIAGNOSIS AND THE PATIENT OUTCOME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584742 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Other